Optimizing Prograf® Therapy in Renal Transplant Patients (OPTIMA)

August 25, 2008 updated by: Astellas Pharma Inc

OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)

A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.

Study Overview

Status

Completed

Conditions

Renal Transplantation

Intervention / Treatment

Drug: Tacrolimus, Prograf®

Detailed Description

A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients

Study Type

Interventional

Enrollment (Actual)

323

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35294
- Arkansas
  - Little Rock, Arkansas, United States, 72205
- California
  - Los Angeles, California, United States, 90057
  - Palo Alto, California, United States, 94304
  - San Diego, California, United States, 92123
  - San Francisco, California, United States, 94115
- Colorado
  - Denver, Colorado, United States, 80262
- District of Columbia
  - Washington, District of Columbia, United States, 20037
- Georgia
  - Atlanta, Georgia, United States, 30309
  - Augusta, Georgia, United States, 30912
- Hawaii
  - Honolulu, Hawaii, United States, 96817
- Illinois
  - Peoria, Illinois, United States, 61603
- Indiana
  - Indianapolis, Indiana, United States, 46202
- Louisiana
  - Shreveport, Louisiana, United States, 71103
- Maine
  - Portland, Maine, United States, 04102
- Massachusetts
  - Boston, Massachusetts, United States, 02114
- Michigan
  - Ann Arbor, Michigan, United States, 48109
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
- Nebraska
  - Omaha, Nebraska, United States, 68198
- New Jersey
  - Livingston, New Jersey, United States, 07039
  - West Orange, New Jersey, United States, 07052
- New York
  - Buffalo, New York, United States, 14203
  - Long Island, New York, United States, 11794
  - Mineola, New York, United States, 11501
  - New York, New York, United States, 10016
  - New York, New York, United States, 10032
  - New York, New York, United States, 10021
- North Carolina
  - Greenville, North Carolina, United States, 27834
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
  - Philadelphia, Pennsylvania, United States, 19104
  - Philadelphia, Pennsylvania, United States, 19107
  - Philadelphia, Pennsylvania, United States, 19141
  - Philadelphia, Pennsylvania, United States, 19102
- South Carolina
  - Charleston, South Carolina, United States, 29425
- Tennessee
  - Nashville, Tennessee, United States, 37232
- Texas
  - Dallas, Texas, United States, 75204
  - Galveston, Texas, United States, 77555
  - San Antonio, Texas, United States, 78284
- Utah
  - Salt Lake City, Utah, United States, 84132
- Virginia
  - Richmond, Virginia, United States, 23298
- Washington
  - Seattle, Washington, United States, 98104
  - Spokane, Washington, United States, 99208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient was 18 years of age at the time of transplant.
Patient is at least 6 months post-transplant.

Exclusion Criteria:

Patient is the recipient of a solid organ transplant other than the kidney.
Patient is a known carrier of any of the HIV viruses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The effect of conversion from cyclosporine to Prograf-based therapy on renal function Time Frame: 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival Time Frame: 24 months	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, Inc.

Investigators

Study Director: John Holman, MD, Astellas Pharma US, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria